Policy & Regulation
Purdue Pharma announces enrolment of first patient Phase 1 investigator-initiated clinical trial of tinostamustine treatment for glioblastoma
6 November 2018 -

Purdue Pharma LP, a provider of prescription medicines, revealed on Tuesday that the first patient has been enrolled in a Phase 1 investigator-initiated clinical trial of tinostamustine, an investigational treatment, in patients with newly-diagnosed common and aggressive type of primary malignant brain tumour, unmethylated O6-Methylguanine-DNA-methyltransferase (MGMT) glioblastoma multiforme (unmethylated nGBM).

The open-label, non-randomised trial is now open at The University of Texas MD Anderson Cancer Center and will investigate the safety profile, maximum tolerated dose (MTD) and efficacy of tinostamustine.

The company said glioblastoma is an incurable cancer with a very poor prognosis. Median overall survival is only 15 months and survival rates have shown no notable improvement in the past 30 years. Currently, standard of care for the disease includes surgery and postoperative radiation therapy with concurrent and adjuvant chemotherapy using temozolomide.

Patients with the unmethylated MGMT form of glioblastoma have a significantly worse prognosis because that tumour type is less likely to respond to currently available treaments. Under current standard of care, the two-year overall survival rate was 46% in patients with MGMT-methylated nGBM compared to 14% in patients with unmethylated nGBM.

Tinostamustine is an investigational treatment and it is not approved for use in glioblastoma patients. The treatment is also in development for a range of rare or difficult-to-treat blood cancers and advanced solid tumours.



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